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Completed

NCT Number: NCT01577563

Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS).

RATIONAL is a multinational, multicentre, observational, cross sectional study of adult patients in treatment with NSAID therapy for OA, RA or AS during for at least 2 weeks before study visit (at least one dose).

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Key information

Conditions

Osteoarthritis (OA) Ankylosing Spondylitis (AS) Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Rheumatoid Arthritis (RA) Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Avellaneda, Argentina

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About this study

Prevalence study of gastrointestinal risk factors in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving treatment with non- steroidal anti- inflammatory drugs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of subject informed consent.
  • Female and/or male, aged > 21 years.
  • Patients diagnosis with RA (ACR 1987 or ACR/EULAR 2010 criteria), OA (ACR 1986, 1990 and 1991 criteria) or AS (New York 1984 criteria or ESSG 2002 criteria) (documented in the medical record).
  • Patients receiving at least one dose of NSAIDs.

Exclusion criteria

  • Participation in any interventional study involving investigational drugs.
  • Patient refuses to fill in the study questionnaires.
  • Pregnant or breastfeeding women.
  • Patients with active neoplastic disease in the last 5 years, except basal-cell carcinoma.

Treatment and study plan

Primary outcomes

  1. Number of subject with age above 60 years.

    Time frame: Up to 4 weeks.

  2. Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs.

    Time frame: Up to 4 weeks.

  3. Number of patients with previous ulcer history.

    Time frame: Up to 4 weeks.

  4. Number of patients with previous ulcer bleeding history.

    Time frame: Up to 4 weeks.

  5. Number of patients with history of dyspepsia.

    Time frame: Up to 4 weeks.

Secondary outcomes

  1. Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status.

    Time frame: Up to 4 weeks.

  2. Descriptive profile of medical history: nicotine use, relevant medical conditions, history peptic ulcer, chronic drug therapy related to relevant medical conditions.

    Time frame: Up to 4 weeks.

  3. Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI.

    Time frame: Up to 4 weeks.

  4. Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis.

    Time frame: Up to 4 weeks.

  5. Descriptive profile of Health Care Resources consumption: number of hospitalizations due to the rheumatic disorder and/or GI complications.

    Time frame: Up to 4 weeks.

  6. Gastrointestinal Symptoms Rating Scale (GSRS).

    Time frame: Up to 4 weeks.

    Rating scale for gastrointestinal symptoms in patients, consisting of five areas: reflux syndrome, abdominal pain, constipation syndrome, diarrhoea syndrome and indigestion syndrome.

  7. Treatment Satisfaction for medication for OA patients (TSQM).

    Time frame: Up to 4 weeks.

    Assessment of patients' satisfaction with medication, providing scores on four scales: side effects, effectiveness, convenience and global satisfaction.

  8. Treatment adherence (Morisky Medication Assessment Scale- MMAs-4).

    Time frame: Up to 4 weeks.

    A generic self-reported, medication-taking behaviour scale in which the specific health issue (e.g. rheumatic pain and dyspepsia) is inserted for the "health concern". The MMAS-4 consists of four items with a scoring scheme of "Yes" = 0 and "No" = 1. The items are added together to give a range of scores from low adherence to high adherence (0 to 4).

  9. Patient Quality of Life (EQ-5D).

    Time frame: Up to 4 weeks.

    The questionnaire consists of 2 aspects: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems and severe problems.

  10. Osteoarthritis Index capturing elements of pain and physical disability (WOMAC VA3.1).

    Time frame: Up to 4 weeks.

    Osteoarthritis Index, self-administered, to report health status which is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).

  11. Health Assessment Questionnaire (HAQ).

    Time frame: Up to 4 weeks.

    Comprehensive measure of outcome in patients with a wide variety of rheumatic diseases.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis Receiving Treatment With Non- Steroidal Anti- Inflammatory Drugs.

Acronym: RATIONAL

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2012
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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